| CTRI Number |
CTRI/2024/06/068614 [Registered on: 10/06/2024] Trial Registered Prospectively |
| Last Modified On: |
29/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To study the effect of unani medicine in Pelvic inflammatory disease |
|
Scientific Title of Study
|
Therapeutic evaluation of unani formulation in management of Pelvic inflammatory disease (Warm-e-aza-e-ana) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Roohina Jabeen |
| Designation |
PG Scholar |
| Affiliation |
Government Nizamia Tibbi College And General Hospital |
| Address |
PG department of Qabalat wa Niswan, OPD no. 08, Government Nizamia Tibbi College And General Hospital, Charminar, Hyderabad
Hyderabad
TELANGANA
500002
India |
| Phone |
7780590046 |
| Fax |
|
| Email |
mrrohinarohina@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Syeda Abidunnisa |
| Designation |
PG Professor |
| Affiliation |
Government Nizamia Tibbi College And General Hospital |
| Address |
PG department of Qabalat wa Niswan, OPD no. 08, Government Nizamia Tibbi College And General Hospital, Charminar, Hyderabad
Hyderabad
TELANGANA
500002
India |
| Phone |
9492027082 |
| Fax |
|
| Email |
syedaabidunnisa@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Roohina Jabeen |
| Designation |
PG Scholar |
| Affiliation |
Government Nizamia Tibbi College And General Hospital |
| Address |
PG department of Qabalat wa niswan, OPD no. 08, Government Nizamia Tibbi College And General Hospital, Charminar, Hyderabad
Hyderabad
TELANGANA
500002
India |
| Phone |
7780590046 |
| Fax |
|
| Email |
mrrohinarohina@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Nizamia Tibbi College And General Hospital, Charminar, Hyderabad, Telangana |
|
|
Primary Sponsor
|
| Name |
Government nizamia tibbi college and general hospital |
| Address |
Government Nizamia Tibbi College And General Hospital, Charminar, Hyderabad, Telangana, 500002 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Roohina Jabeen |
Government Nizamia Tibbi College And General Hospital |
OPD Number 08, PG Department of Ilmul Qabalat Wa Niswan
Hyderabad
TELANGANA |
7780590046
mrrohinarohina@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N74||Female pelvic inflammatory disorders in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1.Arq-E-Baranjasif
2.Vaginal Pessary |
1. Arq-E-Baranjasif, PO, 60 Ml, BD for 3 months
2. Vaginal Pessary for 3 months |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1. Women of reproductive age i.e, 20 years - 40 years
2. Married and Non-Pregnant women
3. USG reports suggestive of Pelvic Inflammatory Disease |
|
| ExclusionCriteria |
| Details |
1. Patient Suffering From Pelvic Inflammatory Disease With Surgical Emergency
2. Pregnant Women and Lactating Women
3. Patients with Appendicitis, Septic Abortions and Ovarian Cyst.
4. Women With Serious Medical Illness, CVD, Respiratory Diseases, Renal Disorders, TB.
5. Women With Serious Gynaecological Disorder like Pelvic Carcinoma and Systematic Disease. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in Subjective Parameters Like Abnormal White Discharge, Lower Abdominal Pain, Nausea and Vomiting, Fever with chills, Dyspareunia and Dysuria |
At baseline and every 30th day for 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in Congested Cervix, purulent Discharge, Tenderness in Both Quadrants Of Lower Abdomen, On P/V decreased Abnormal Vaginal Discharge |
At baseline (0th day), 30th day, 60th day and 90th day |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
12/06/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Pelvic inflammatory disease
is a common female gynecological disorder in the women of reproductive age.
This study is a single arm, single-blinded, clinical trial on patients with
Pelvic inflammatory disease with unani formulation for a total of 30 patients in
India. The treatment will be given for 3 months. The subjective and objective
parameters will be assessed on 0th day, 30th day, 60th day and 90th day.
|